The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines

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The official letter 12509/QLD-ĐK
The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines
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The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines

MINISTRY OF HEALTH

DRUG ADMINISTRATION OF VIETNAM

SOCIALIST REPUBLIC OF VIETNAM

Independence – Freedom – Happiness

No.: 12509/QLD-ĐK

Re: Amending way of writing indication of Glucosamine-containing medicines

       Hanoi, 05 August 2013

To:   

  • Provincial/municipal Departments of Health;
  • Hospitals, institutes with beds belong to the Ministry of Health;
  • Applicants, manufacturers have drugs marketing in Vietnam.

After the official letter 6132/QLD-ĐK dated June 16, 2010 by Drug Administration of VN about way of writing indication, contra-indication and dosage of glucosamine-containing medicines and based on the conclusions of the advisory Board of the issuance of medicine registration numbers – Ministry of Health for indication of Glucosamine-containing medicines; to ensure objective for using drugs reasonably, safely and effectively, Drug Administration notify as follows:

  1. Amending way of writing indication of glucosamine-containing medicines in the official letter 6132/QLD-ĐK dated June 16, 2010 by Drug Administration of VN is “Relief the mild to moderate symptoms of knee osteoarthritis”. The content of writing guidelines contra-indication, dosage of the drug is uniformly applied as the official letter 6132/QLD-DK dated June 16, 2010 by Drug Administration of Vietnam.
  2. Suggest Provincial/municipal Departments of Health and hospitals, institutes with beds belong to Ministry of Health: inform medical units, companies on the local about the information related to indication of glucosamine at above item 1.
  3. Applicants, manufacturers:
    • For glucosamine-containing medicines have been licensed for marketing:
  • Within 3 months from the date of signing of this official letter. Request applicants, manufacturers to implement: edit the information of indication is “Relief the mild to moderate symptoms of knee osteoarthritis” in related parts of label, package insert and/or patient information leaflet.
  • Updated form: Submit variation/supplement dossier information on label, package insert and/or patient information leaflet following the instruction at Annex II – Circular 22/2009/TT-BYT dated 24/11/2009 of the Ministry of Health, guiding medicine registration.
    • For drug registration dossiers with glucosamine-containing ingredient pending approval at Drug Administration of Vietnam:
  • Drug Administration only considers grant registration numbers after applicants submitted variation/supplement documents of section indication as above mention at item 1 into related documents of dossier and satisfactory evaluation.

Drug Administration of Vietnam notifies units to know and implement.

  DEPUTY CHIEF OF DRUG ADMINISTRATION
  (signed and stamped) NGUYEN VAN THANH

The official letter 12509/QLD-ĐK Amending way of writing indication of Glucosamine-containing medicines

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